Change in immediate verbal memory from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in delayed verbal memory from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the Delayed Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in visual memory from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the Picture Sequence Memory Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in executive function from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the Dimensional Change Card Sort Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in pattern comparison processing speed from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the Pattern Comparison Processing Speed Test. This test asks participants to determine whether two stimuli are the same or not the same as quickly as possible without making mistakes. It is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in processing speed from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the Oral Symbol Digit Test. This test assesses time needed to process pairings of digits & symbols and is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in plasma amyloid 42/40 ratio from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using commercial Meso Scale Discovery (MSD) assays
Change in plasma phosphorylated tau 231 from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using commercial Meso Scale Discovery (MSD) assays
Adjudication for Mild Cognitive Impairment (MCI) [ Time Frame: Performed using data collected at 6-months and 9-months ]
Investigator-consensus adjudication will be performed by three investigators to determine if a participant has diagnosable MCI according to the NIA-AA guidelines (Albert et al., 20211).
Change in body weight from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Measured in kilograms using an electronic scale
Change in BMI from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Calculated using the formula: weight (in kilograms) / height (in meters)^squared
Change in blood pressure (mmHG) from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest
Change in fasting plasma glucose (mg/dL) from baseline to 6- and 9-months [ Time Frame: baseline, 6-months, 9-months ]
Assessed using an automated chemistry analyzer
Change in serum lipids (mg/DL) from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed
Change in insulin sensitivity (µIU/mL) from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Calculated using homeostatic model assessment (HOMA)
Change in depressive symptoms from baseline to 6- and 9-months [ Time Frame: Assessed at baseline, 6-months, 9-months ]
Assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977). This scale has a possible score range 0 to 60, with higher scores indicating greater frequency of depressive symptoms.
Protocol Adherence [ Time Frame: Assessed at 6-months and 9-months ]
Number of days Fitbit worn, number of days Fitbit synced, number of weeks study arm specific PA goal met, and number of individual coaching meetings attended.
Treatment acceptance [ Time Frame: Assessed at 6-months and 9-months ]
Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.
Source: View full study details on ClinicalTrials.gov
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